BEUDAMED
    FDA Registration Active 🇺🇸 United States

    G4Derm / G4Derm Plus Synthetic Wound Matrix

    Reg #: 3016504086 · FEI: 3016504086 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    GEL4MED, INC.
    Registration Number
    3016504086
    FEI Number
    3016504086
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    110 Canal St, 2nd floor
    City
    Lowell
    State
    MA
    ZIP
    01852
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222025

    Owner / Operator

    Firm Name
    Gel4Med, INC.
    Operator Number
    10089559
    Address
    1660 Soldiers Field Rd, STE 7
    City
    Brighton
    State
    MA
    Postal Code
    02135
    Country
    US

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    G4Derm / G4Derm Plus Synthetic Wound Matrix Suprello

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device